Multiple Myeloma

Multiple Myeloma

Multiple Myeloma

Ongoing Clinical Trials With Bispecific Antibodies

Clinicians must maintain awareness of the latest clinical trials ongoing in the management of multiple myeloma across the bispecific antibody therapies, including single-agent studies, and combinations (Table 3).27

Table 3: Selected Clinical Studies of Bispecific Antibody Therapies in Multiple Myeloma27

Treatment

Title

Link

Linvoseltamab (REGN5458)

First in Human (FIH) Study of REGN5458 in Patients With Relapsed or Refractory Multiple Myeloma (LINKER-MM1)

https://clinicaltrials.gov/ct2/show/NCT03761108

REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Participants With Relapsed/Refractory Multiple Myeloma

https://clinicaltrials.gov/ct2/show/NCT05137054

Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)

https://clinicaltrials.gov/ct2/show/NCT05164250

CC-93269

Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma

https://clinicaltrials.gov/ct2/show/NCT03486067

Elranatamab (PF-06863135)

MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

https://clinicaltrials.gov/ct2/show/NCT05090566

MagnetisMM-8: Study Of Elranatamab (PF-06863135) Monotherapy in Chinese Participants With Refractory Multiple Myeloma

https://clinicaltrials.gov/ct2/show/NCT05228470

MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (MAGNETISMM-5)

https://clinicaltrials.gov/ct2/show/NCT05020236

Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)

https://clinicaltrials.gov/ct2/show/NCT05238311

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant (MagnetisMM-7)

https://clinicaltrials.gov/ct2/show/NCT05317416

A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment (MagnetisMM-9)

https://clinicaltrials.gov/ct2/show/NCT05014412

TNB-383B

A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma

https://clinicaltrials.gov/ct2/show/NCT03933735

Teclistamab (JNJ-64007957)

A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

https://clinicaltrials.gov/ct2/show/NCT04696809

Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

https://clinicaltrials.gov/ct2/show/NCT05463939

A Study of Teclistamab in Combination With Lenalidomide Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (MajesTEC-4)

https://clinicaltrials.gov/ct2/show/NCT05243797

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3)

https://clinicaltrials.gov/ct2/show/NCT05083169

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2)

https://clinicaltrials.gov/ct2/show/NCT04722146

A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)

https://clinicaltrials.gov/ct2/show/NCT04557098

Clinical Toolkit

Burden, Assessment, and Available Therapeutics in MM

Therapeutic Antibodies in Clinical Development

Ongoing Clinical Trials With Bispecific Antibodies

AVAHO

References

This activity is provided by Med Learning Group.
This activity is supported by an independent medical education grant from Regeneron Pharmaceuticals, Inc.
Copyright © 2024 Med Learning Group. Built by Divigner. All Rights Reserved.

Scroll to Top
Home
Clinical Toolkit
Burden, Assessment, and Available Therapeutics in Multiple Myeloma
Therapeutic Antibodies in Clinical Development
Ongoing Clinical Trials With Bispecific Antibodies
References
Patient Toolkit
What is Multiple Myeloma?
What are Antibody Therapies?
Living with Multiple Myeloma
FAQ
Resources
Can We Talk?
CME Activities
Animations
About Us
Contact
Note: This CME program was recorded prior to the American Society of Clinical Oncology (ASCO) 2023 meeting in June 2023. Highlights of data released at ASCO include:

Teclistamab

Longer-term data of the Phase 1/2 MajesTEC-1 study showed a high rate of deep and durable response in triple-class exposed MM patients. At 22 median follow up; complete response or better = 43%; duration of response = 24 months (27 months for ≥CR); median PFS = 12.5 months (20 months for ≥CR); median OS = 21.9 months (not reached for ≥CR).

Adverse event profile for all patients (and grade 3/4) included: infections = 78% (52%); CRS = 72% (0.6%); neutropenia = 72% (65%); anemia = 54% (38%); thrombocytopenia = 42% (22%); and lymphopenia = 35% (33%). ICANS occurred in 3% of patients, all grade 1 or 2.

Reference: van de Donk NWCJ, et al. Long-term follow-up from MajesTEC-1 of teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM). J Clin Oncol. 2023;41(suppl 16):8011. doi:10.1200/JCO.2023.41.16_suppl.8011

Linvoseltamab (investigational)

Two Phase 2 full dose cohorts (50 mg and 200 mg) in the LINKER-MM1 trial were studied to optimize dose selection. Linvoseltamab 200 mg showed better efficacy compared with 50 mg, including in patients with high disease burden. The 200 mg dose had consistent efficacy across high-risk subgroups and induced responses in pts who progressed on 50 mg. The recommended dose for further study is now 200mg.

ORR for 200 mg dose = 71%; CR = 30%; very good partial response = 59%. Median duration of response = not reached. The probability of maintaining response at 6 months was 84% and 79% at 12 months. Treatment-emergent adverse events were reported in 95% of patients (grade 3 or higher = 79%): CRS = 45% (1%); neutropenia = 33%; fatigue = 33%; anemia = 27% (24%). ICANS ≥grade 3 = 2%.

References:

Lee HC, et al. LINKER-MM1 study: Linvoseltamab (REGN5458) in patients with relapsed/refractory multiple myeloma. J Clin Oncol. 2023;41(suppl 16):8006. doi:10.1200/JCO.2023.41.16_suppl.8006

Updated Linvoseltamab (BCMAxCD3) Data from pivotal trial demonstrates early, deep, and durable responses in patients with heavily pre-treated multiple myeloma. News release. Regeneron Pharmaceuticals, Inc; May 25, 2025. Accessed June 15, 2023. https://investor.regeneron.com/news-releases/news-release-details/updated-linvoseltamab-bcmaxcd3-data-pivotal-trial-demonstrates

Elranatamab (investigational)

Pooled data from the MagnetismMM studies were presented. In pts with RRMM and prior exposure to BCMA-directed therapies, elranatamab was efficacious and well tolerated; no new safety signals were observed vs the BCMA-naïve population. ORR = 45.3% (prior anti-BCMA therapy = 41%-53%); median time to OR = 1.9 months; complete response or better = 17.4%; duration of response at 9 months = 72% (prior anti-BCMA therapy = 67.3%-78%); median PFS = 4.8 months; median OS 10-month endpoint not reached, but = 60.1% at 9 months.

Treatment-emergent adverse events in all patients (and grade 3 or higher) included: CRS = 65% (1%); anemia = 59% (47%); neutropenia = 44% (41%); thrombocytopenia = 41% (29%); diarrhea = 34% (0%); lymphopenia = 33% (30%); and ICANS = 6% (2%).

Reference: Nooka AK, et al. Efficacy and safety of elranatamab in patients with relapsed/refractory multiple myeloma (RRMM) and prior B-cell maturation antigen (BCMA)-directed therapies: A pooled analysis from MagnetisMM studies. J Clin Oncol. 2023;41(16 suppl):8008. doi:10.1200/JCO.2023.41.16_suppl.8008